Gastric cooling apparatus

ABSTRACT

A gastric cooling apparatus which can be used for general cooling but which is especially adapted for local cooling, to reduce blood flow in the vessels supplying the stomach wall of a person. The gastric cooling apparatus includes a flexible, inflatable bag for insertion into a patient&#39;&#39;s stomach and to contain a predetermined amount of distilled water. A water cooling means, a vacuum operated reservoir means, and a directional flow control shunt valve are operatively interconnected, whereby when vacuum is applied to the reservoir means, said vacuum will operate the reservoir means to withdraw a first predetermined amount of water from said bag through said shunt valve, and then block off said vacuum to permit said first predetermined amount of water to flow by gravity from said reservoir means and through said shunt valve to said water cooling means while simultaneously forcing a second predetermined amount of cooled water out of said cooling means and into said bag.

United States Patent [191 Gawura GASTRIC COOLING APPARATUS [75]Inventor: Andrew Gawura, Dearborn, Mich.

[73] Assignee: A. Robert Lawrence, Oak Park,

Mich.

[22] Filed: Oct. 6, 1972 [21] Appl. No.: 295,725

3,227,154 1/1966 Cook 128/2 Primary Examiner-Lawrence W. TrappAttorney-Donnelly, Mentag and Harrington [57] ABSTRACT A gastric coolingapparatus which can be used for general cooling but which is especiallyadapted for local cooling, to reduce blood flow in the vessels supplyingthe stomach wall of a person. The gastric cooling apparatus includes aflexible, inflatable bag for insertion into a patients stomach and tocontain a predetermined amount of distilled water. A water coolingmeans, a vacuum operated reservoir means, and a directional flow controlshunt valve are operatively interconnected, whereby when vacuum isapplied to the reservoir means, said vacuum will operate the reservoirmeans to withdraw a first predetermined amount of water from said bagthrough said shunt valve, and then block off said vacuum to permit saidfirst predetermined amount of water to flow by gravity from saidreservoir means and through said shunt valve to said water cooling meanswhile simultaneously forcing a second predetermined amount of cooledwater out of said cooling means and into said bag.

10 Claims, 4 Drawing Figures PATENTEDocr 30 ms SHEET 2 GF 2 GASTRICCOOLING APPARATUS SUMMARY OF THE INVENTION This invention relatesgenerally to a gastric cooling apparatus especially adapted forhypothermically treating locally a condition of the human body, ashemorrhages in the upper gastrointestinal tract.

Upper gastrointestinal hemorrhages continue to be a major threat to lifedespite refinements of medical and surgical therapy. Approximately 16percent of patients having peptic ulcers of the duodenum havecomplications caused by hemorrhages. There are also many other causes ofhemorrhages in the upper gastrointestinal tract. Mortality due to severebleeding from duodenal ulcers occurs in approximately 6 to 13 percent ofthose cases, and in such cases treated surgically, the mortality rate issomewhat higher.

The age of the patient, coincident disease, and duration of bleeding arethe principle determining factors in the prognosis. The age of thepatient and the coincident disease are usually known when the patient isfirst seen. The crucial question is how long and how severely thepatient will bleed. Conservative therapy is then directed towardreplacing blood and limiting or stopping blood loss with the realizationthat mortality and the risk is rising rapidly if this is not achieved inthe first 48 hours. Continued loss of blood after 48 hours usuallyconstitutes a strong indication for surgical intervention, and thesurgeon is often presented with a high risk patient.

Local gastric hypothermia has long been a part of the procedure fortreating hemorrhages in the upper gastrointestinal tract. One form oflocal gastric hypothermia is the use of ice water lavage by confiningthe coolant to a balloon and providing a mechanical means to circulatethe coolant and control its temperature. It has been found that localcooling reduces blood flow in the vessels supplying the stomach wall,decreases motility of the stomach and inhibits the secretion ofhydrochloric acid and pepsin from the gastric mucosa. In addition, thereis some local tamponade effect of the balloon in close apposition to thebleeding site or sites within the mucosa.

Heretofore, a water lavage method has been used which included theinsertion of a tube into a patient and then injecting a predeterminedamount 'of ice water into the patients stomach through the tube, andafter a few minutes, withdrawing the water with the same device as, forexample, a syringe. This procedure was repeated time and time againuntil no sign of blood was found along the Levine tube fastened to thesyringe. A disadvantage of this method is that it is slow and anattendant is constantly required.

Other methods for cooling a patients stomach have been employed whichinclude the use of a ballon having a plurality of conduits forconducting coolant into the balloon and then out of the balloon, andwith the coolant comprising alcohol. A disadvantage of the lastmentioned method of hypothermia is that there is danger of freezing thestomach of the patient. Also, if the balloon is broken or'punctured, thealcohol is dumped into the patients body with a resultant injuriouseffect on the patient. Furthermore, a refrigeration unit is required anda technician is required to be present at all times to keep continuouswatch on the equipment. A further disadvantage of such prior art devicesis that they require a double tube, and accordingly, it is difficult topass a double tube down into the stomach of a patient, and it is veryuncomfortable to the patient.

In view of the foregoing, it is an important object of the presentinvention to provide a novel and improved gastric cooling apparatuswhich overcomes the aforementioned disadvantages of the prior artgastric cooling apparatuses.

It is another object of the present invention to provide a novel andimproved gastric cooling apparatus which is simple and compact inconstruction, economical to manufacture, and which is efficient inoperation.

It is still another object of the present invention to provide a noveland improved gastric cooling apparatus which includes a flexible,inflatable bag for insertion into the stomach of a patient, a watercooling means, a vacuum operated reservoir means operatively connectedto a vacuum source, a flow control shunt valve, fluid conduit meansoperatively interconnecting said shunt valve, said reservoir means, saidwater cooling means and said flexible, inflatable bag, whereby whenvacuum is applied to the reservoir means, said vacuum will operate saidreservoir means to withdraw a first predetermined amount of water fromsaid bag through said valve, and then block-off said vacuum to permitsaid first predetermined amount of water to flow by gravity from saidreservoir means and through said valve to said water cooling means whilesimultaneously forcing a second predetermined amount of cool water outof said cooling means and into said bag. The bag comprises an ordinarytoy plastic balloon which affords an automatic means of removinggasesdiffusing into the balloon and to prevent undetected gastric distemsion. Accordingly, since the water is not pumped into the balloon, it isfail-safe in that the patient can only receive an amount of water equalto the contents of the balloon if the balloon were to break or bepunctured. In case of any failure in the apparatus circuit, the resultis merely the stoppage of the cycle. The use of ice and water affordsexcellent control of temperature, as well as freedom from hazard ofthermostatic control failure as might occur in a refrigeration unit ofthe prior art apparatuses. The gastric cooling apparatus of the presentinvention comprises a single small diameter nasogastric tube forattachment to the balloon and for passing down through the nasal passageof the patient so as to avoid the discomfort of a large double channeltube which is necessary in the continuous flow methods employed in theprior art devices. Also, the simplicity of operation of the apparatus ofthe present invention allows the nursing staff at the bedside .to havefull and safe control of the procedure without the need for any specialattendant or nursing care. The temperature of the water and of thepatient is constantly monitored by a suitable thermistor probe in thecircuit and by rectal temperatures, respectively. A, warming blanket maybe employed for comfort as well as prevention of general hypothermia.

The gastric cooling apparatus of the present invention is alsoadvantageous because it is soundless and disposable.

Other features and advantages of this invention will be apparent fromthe following detailed description, appended claims, and theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top plan view of a gastriccooling apparatus, made in accordance with the principles of the presentinvention.

FIG. 2 is a broken, elevational section view of the structureillustrated in FIG. 1, taken along the line 22 thereof, looking in thedirection of the arrows, and showing the gastric cooling apparatus in anoperative condition for initiating a cycle to withdraw water from aballoon in a patients stomach.

FIG. 3 is a horizontal, section view of the structure illustrated inFIG. 2, taken along the line 33 thereof, and looking in the direction ofthe arrows.

FIG. 4 is a broken, elevational section view, similar to FIG. 2, andshowing the gastric cooling apparatus in an operative condition forinitiating a cycle to feed cooled water into a balloon in a patientsstomach.

DESCRIPTION OF THE PREFERRED EMBODIMENT Referring now to the drawings,and in particular to FIG. 2, the numeral 8 generally designates aflexible, inflatable bag in the form of an ordinary toy balloon, whichis operatively connected to a directional flow control shunt valvegenerally indicated by the numeral 10 and to a vacuum operated fluidreservoir generally indicated by the numeral 9. The balloon 8 may bemade from any suitable plastic material, and it is porous to the extentthat the acids and gases that accumulate in a patients stomach will passinto the balloon and will be sucked out in the next cycle of water anddrawn from the balloon 8.

The balloon 8 is provided with a narrow neck 11 that is provided with apassage 12 through which is extended one end 13 of a suitablenasogastric tubing 14. The tubing 14 is made from any suitable plasticmaterial, as for example, from TEFLON or DELRIN plastic. The tubing 14would be adhered to the outer surface of the fluid entrance passage 12by any suitable means, as by a suitable adhesive. As shown in FIG. 2,the inner end 13 of the tubing 14 is provided with a plurality of outletports 15 and an end opening 16. The tubing 14 preferably has a 3/16 inchouter diameter and an inch inner diameter to provide a desired flow ofwater therethrough.

As shown in FIG. 2, the outer end 17 of the nasogastric tube 14 isoperatively mounted over the outer end 18 of a fitting 19. The fitting19 has an enlarged inner end 20 which is adhered by any suitableadhesive or cement in one end of an enlarged flow passage 21 in a shuntvalve block 22. The fitting 19 is provided with a passage 23therethrough for communicating the passage 21 with the tubing 14. Theother end of the valve passage 21 communicates with a reduced diameterpassage 24. A valve seat 25 is formed at the inner end of the reduceddiameter passage 24 for the reception of a suitable ball check valve 26.The outer end of the passage 24 communicates with an enlarged threadedpassage 27 in which is threadably mounted a suitable tubing fitting 28which has operatively connected thereto a suitable plastic tubing 29made from the same material as the tubing 14.

The other end of the tubing 29 is operatively connected to the outletend 30 of a suitable refrigerated copper tube cooling unit, generallyindicated by the numeral 31. Any conventional suitable cooling unit maybe employed. The inlet end 32 of the cooling unit 31 is operativelyconnected to one end ofa suitable plastic tubing 33 made from the samematerial as the tubings 14 and 29. The other end of the tubing 33 isoperatively connected to a fitting 34 which is threadably mounted in athreaded hole 35 in the valve block 22. The threaded passage 35 isdisposed perpendicular to the first fluid passage 21 and a second fluidpassage 37 in the block 22. The passage 37 communicates with thethreaded passage 35 through an interconnecting bore or passage 36.

One end of the passage 37 communicates with a reduced diameter passage38 which in turn communicates with an enlarged passage 38a that isenclosed by a plug 41. The plug 41 is adhered in place in the bore 380by any suitable means, as by a suitable adhesive or cement. A valve seat39 is formed at the inner end of the passage 33 and operatively receivesa ball check valve 40. The ball check valves 26 and 40 may be made fromsteel or any other suitable material. The bore 38a is in communicationwith a passage 42 that is connected to the passage 21.

As shown in FIG. 2, a means for monitoring the temperature of the fluidin the passage 21 is provided, and it comprises a conventionalthermistor probe 44 which has its inner end 43 disposed in the passage21. The thermister probe 44 is operatively mounted in a fitting 45 whichis fixedly mounted in a bore 47 inside of the valve block 22, and withthe inner end 43 of the probe extending through an interconnectingpassage 43 into the passage 21.

As shown in FIG. 2, the other end of the passage 37 is enclosed by theinner end 48 of a fitting 49. Fitting 49 is secured in place by anysuitable means, as by a suitable adhesive or cement. The fittings 19, 45and 49, the plug 41, and the valve body or block 22, may be made fromany suitable material, as for example, a suitable plastic material. Thefitting 49 is provided with a reduced outer end 50 and with a passage 51formed therethrough. The passage 51 communicates the valve passage 37with the interior of a suitable plastic tubing 53. One end 52 of thetubing 53 is fixedly secured by any suitable means to the fitting outerend 50. The other end 54 of the tubing 53 is fixedly secured by anysuitable means to the reduced outer end 56 of a suitable fitting 57 onthe reservoir body 55. The fitting 57 has an enlarged inner end which issecured in a central axial bore in the lower end wall 60 of thereservoir body 55. A passage 59 through the fitting 57 communicates thetubing 53 with a interior chamber 61 in the reservoir body 55.

As shown in FIG. 2, the reservoir 9 includes the cylindrical body 55which is made from a suitable plastic material, and which has its upperend enclosed by a cap generally indicated by the numeral 62. The cap 62includes a plate 63, on the inner side of which is formed a circular,inwardly extended flange 64 that is seated in the upper end of thecylinder or reservoir body 55. The flange 64 is secured in place by anysuitable means, as by a suitable adhesive or cement. It will beunderstood that the reservoir cap 62 is made from the same suitableplastic as the cylinder or body 55 and the lower end cover 60. A ventpassage 65 is formed through the cap wall 63 for venting the upper endof the chamber 61.

As shown in FIG. 2, the reservoir cap 62 is provided on the inner sideof the cap wall 63 with an inwardly extended axial projection 66, on theinner end of which is formed a flat valve seat 67 around the inner endof a vacuum passage 68. The vacuum passage 68 communicates at its outerend with a second vacuum passage 69 formed through a radially andoutwardly extended integral projection 70 formed on the outer side ofthe cover 62. The outer end of the passage 69 is enlarged, as indicatedby the numeral 71, and fixedly secured therein is a check valve,generally indicated by the numeral 72.

As shown in FIG. 2, the valve 72 includes a threaded body which isprovided on its inner end with a passage 73 that communicates with thevacuum passage 69. The inner end of the valve passage 73 communicateswith a spring chamber 74 in which is seated a coil spring 75. Spring 75normally biases a steel ball check valve 76 outwardly into operativeengagement against a valve seat formed on the inner end of a threadablymounted plug 77 which is disposed in the outer end of the spring passageor bore 74. A passage 78 is formed through the plug 77.

As shown in FIG. 2, the vacuum passage 69 also communicates through apassage 79 with a passage 80 formed through a tubing fitting, generallyindicated by the numeral 81. The inner end of the tubing fitting 81 isfixedly mounted by any suitable adhesive or cement in an enlargedpassage 83 that communicates with the passage 79. The reduced outer end84 of the fitting 81 has operatively mounted thereon one end of asuitable tubing, generally indicated by the numeral 85. The tubing 85 isoperatively connected to a suitable conventional electrically operatedvacuum pump.

As shown in FIG. 2, the reservior 9 includes a float valve, generallyindicated by the numeral 86, which is formed as an elongated cylinder 87made from a suitable plastic material. The lower end of the valvecylinder 87 is enclosed by an elongated plug 88 which has formedtherethrough an axial passage 89. The plug 88 is fixed in place in thelower end of the cylinder 87, by any suitable means, as by an adhesiveor cement. A plurality of suitable bumpers or stoppers 90, made from anysuitable materiaL'are operatively mounted on the lower end of the floatvalve 86.

The upper end 91 of the plug passage 89 communicates with the interiorof the valve cylinder or body 87 and has formed on opposite sidesthereof a pair of angled'slots 93, whereby fluid may pass through these.

slots when a float ball 92 is seated on the inner end 91 of the passage89. The float ball 92 may be'made from any suitable material, as forexample, a plastic material, and with weight added therein, as forexample, a fluid, to provide a weight of approximately 2 or 3 grams forurging the valve 86 downwardly after it has been raised by vacuum, asdescribed more fully hereinafter.

As shown in FIG. 2, the valve body or cylinder 87 is provided with aplurality of ports or openings 94 that communicate the upper end of thevalve body 87 with the reservoir chamber 61. The upper end of the valvebody 87 is enclosed by a suitable diaphragm 95 made from a suitableplastic or elastic material, and it is held in place by a suitablecircular plastic cap 96 provided with an opening 97.

In use, the balloon 8 will be in a flat, collapsed and extendedcondition, whereby it may be inserted into a patients nasal passage anddown into the patients stomach. A predetermined amount of fluid isinserted through the tubing 14 to the balloon 8, as for example,

approximately 600 to 650 cubic centimeters of distilled water. Thetubing 14 is then connected to the directional flow control shunt valvefitting 19. It will be understood that the float valve 86 would be inthe lowered position shown in FIG. 2, and that the other part of thecircuit including the cooling means 31 will have been charged withdistilled water.

The patient is in a sitting position for the inserting of the balloon 8,and after this procedure, the patient lies down with the reservoir beingdisposed in a position a few feet above the patient to provide thenecessary gravity created pressure head operation of the coolingapparatus. With the balloon 8 in position in a patients stomach, andwith the cooling apparatus fully charged and connected to the vacuumsource, the vacuum source is actuated so as to exert a vacuum on thepassages 80, 79, 69 and 68, and the chamber 61 in the reservoir cylinder55. The spring 75 maintains the check valve 76 in the position shown inFIG. 2, so as to close off the passage 69 from the atmosphere. Thevacuum is maintained at approximately 5 to 7 inches of mercury. Thevacuum in the reservoir chamber 61 will lift a column of water from theballoon 8 in accordance with the internal dimensions of the reservoirchamber 61 and the other interconnecting structure. It has beendetermined that a predetermined amount of water of approximately 50 to80 cubic centimeters is desirable, to be withdrawn from the balloon 8and exchanged with an equal amount of cooled water. Accordingly, thevacuum operating in the chamber 61 will pull this predetermined amountof water from the balloon 8 through the tubing 14 and thence through thevalve passages 21, 42, 38, 37 and through the tubing 53 into the lowerend of the chamber 61.

The water entering the chamber 61 will pass up through the float valvepassage 89 and up to the ports 94 at which point the float valve 86 willmove upwardly and move the diaphragm 95 into the position shown in FIG.4, so as to block off the vacuum passage 68. When the passage 68 isclosed by the diaphragm 95, the check valve 76 moves inwardly to theposition shown in FIG.

' 4, and gravity takes over. The water that has been lifted into thereservoir 9 then flows downwardly through the tubing 53 and into thevalve passage 37. The positions of the check balls 26 and 40 are thenreversed from the position shown in FIG. 2. That is, as shown in FIG. 4,the check valve 40 blocks off the passage 38 and the check ball 26 opensso that the predetermined amount of water being forced out of thereservoir 9 will pass from the passage 37 into the tubing 33 and throughthe cooling means 31, while simultaneously forcing a secondpredetermined amount of water upwardly through the tubing 29 into thevalve passage 21, and then to the tubing 14 into the balloon 8. Thefloat ball 92is provided as a weight means to ensure that the floatvalve 86 will move downwardly and break away from the vacuum valve seat67 as the water moves out of the reservoir 9 by gravity.

It will be seen that the cooling apparatus of the present invention is asimple, compact, efficiently operating apparatus. It can be madeeconomically, so as to be disposable. The constant interchanging of apredetermined amount of water in the balloon maintains a desiredtemperature. The apparatus can be made to cycle in a predetermined timeinterval as, for example, one complete cycle every 15 seconds. Theinterchange of the units of cooling water in the balloon makes itpossible to maintain the temperature of the water in the balloon betweencertain limits as, for example, from 3-7 C. The apparatus of the presentinvention does not require a technician to control it or to monitor it.The nursing staff on duty on the hospital floor can look at itfrequently and check it to see that it is working properly. The onlystep in the procedure of using the apparatus that requires a physicianis the inserting of the balloon 8 into the stomach of a patient, and inmany cases this can be done by a competent nurse.

Experience has shown that the apparatus of the present invention is veryuseful and practical. It has been used in the treatment of esophagealand gastric hemorrhage in patients with malignancies. Patients treatedwith the apparatus of the present invention comprises three categories,namely, patients bleeding from eroded arteries in gastric carcinoma;patients bleeding from steroid induced multiple gastric ulcers or stressulcers; and, patients with bleeding from esophageal varicies from portalhypertension secondary to massive hepatic metastases.

It has been found that it takes from 20 to 30 minutes to obtain the unitfrom the place where it may be stored and completely set it up andinstruct the floor nurse in its use if she is not familiar with it, andto write whatever necessary orders are required. There are not untowardcomplications in setting up the apparatus. There is no detrimentaleffect if the balloon 8 should rupture inside the stomach of a patient.Since the water in the balloon 8 is maintained between 37 C, there havebeen no complications as caused by the earlier prior art freezingmethods.

In actual use, the apparatus of the present invention has given patientsthe time needed for use of the specific therapy indicated in each case,whether surgery, corticoid steroid reduction, high dose radiationtherapy, chemotherapy, etc. The apparatus of the present invention hasbeen impressive from the standpoint of the speed with which hemorrhageshave been controlled. For example, hemorrhages have been controlledwithin 2 hours, and nearly always within 8 hours. It has been found thata minimal amount of nursing time is required to supervise the apparatusof the present invention. As for example, no more than 30 minutes per8-hour shift is required. The apparatus of the present invention meetsthe goal of therapy which is to control life-threatening hemorrhages.

While it will be apparent that the preferred embodiment of the inventionherein disclosed is well calculated to fulfill the objects above stated,it will be appreciated that the invention is susceptible tomodification, variation and change.

What is claimed is:

1. A gastric cooling apparatus comprising:

a. a flexible, inflatable bag for insertion into a patients stomach;

b. a water cooling means having an inlet and an outlet;

c. a vacuum operated reservoir means operably connected to a vacuumsource;

d. a directional flow control shunt valve;

e. means operatively interconnecting said shunt valve, said reservoirmeans,- said water cooling means and said flexible, inflatable bag,whereby when vacuum is applied to the reservoir means, said vacuum willoperate said reservoir means to withdraw a first predetermined amount ofwater from said bag through said valve, and then block off said vacuumto permit said first predetermined amount of water to flow by gravityfrom said reservoir means and through said valve to said water coolingmeans while simultaneously a second predetermined amount of cooled wateris forced out of said cooling means and into said bag.

2. A gastric cooling apparatus as defined in claim 1,

wherein:

a. said vacuum operated reservoir means includes a cylindrical reservoirbody having a vacuum passage connected at one end thereof which isconnected to said vacuum source, and the other end thereof beingconnected to said shunt valve, and a float valve operatively mounted insaid reservoir body for blocking said vacuum passage when apredetermined amount of water has been drawn into said reservoir body.

3. A gastric cooling apparatus as defined in claim 2,

wherein:

a. said float valve includes a hollow cylindrical body having adiaphragm on one end thereof for blocking said vacuum passage and beingopen at the other end thereof.

4. A gastric cooling apparatus as defined in claim 3,

wherein:

a. said float valve includes a plurality of ports formed through thewall of said cylindrical body and a weight means movably mounted insideof said cylindrical body.

5. A gastric cooling apparatus as defined in claim 4,

wherein:

a. said reservoir means cylindrical body is provided with a vent meansat said one end thereof.

6. A gastric cooling apparatus as defined in claim 5,

wherein:

a. said reservoir means vacuum passage is provided with a check valvemeans.

7. A gastric cooling apparatus as defined in claim 1,

wherein:

a. said flow control shunt valve includes means for providing a firstcircuit therethrough to interconnect said bag with said reservoir meanswhen said reservoir means is vacuum operated, and a second circuittherethrough to interconnect said bag with said water cooling means andsaid reservoir means when said first predetermined amount of water flowsby gravity from said reservoir means so asto simultaneously force saidsecond predetermined amount of cooled water into said bag.

8. A gastric cooling apparatus as defined in claim 1,

wherein said flow control shunt valve includes:

a. a body;

b. a first passage means formed in said body and having one endinterconnected to said bag and the other end connected to the outlet endof said water cooling means;

0. a second passage means formed in said body and having one endconnected to said reservoir means and the other end connected to saidfirst passage means at a point intermediate its ends;

d. said connecting means including conduit means connecting the inletend of said water cooling means to said second passage means at a pointintermediate its ends; and,

e. a check valve means operatively mounted in each of said first andsecond passage means at said other check valve. 10. A gastric coolingapparatus as defined in claim 8, including:

a. a temperature indicating means operatively mounted in said firstpassage means in said body for indicating the temperature of the waterflowing therethro ugh.

UNHTEU STATES PATENT @FFKQE I QEERTEFHQAWE @F QQRREQTEN BJ7 S L8LL DatedOctober 30, 1973 Patent No Inventor(s) Andrew Gawura It is certifiedthat error appears in the above-identified patent and that said LettersPatent are hereby corrected as shown below:

Col. 3, line 45 "5/8"shou1d be 1/8 Col. 7, line 15 "cornprises" shouldbe M comprise a,

Signed and sealed this 5th day of March 197%,

(SEAL) Att est:

EDWARD M.FLETCHER, JRa .Attesting Officer Co MARSHALL DANN Gornmi ssioner of Patent s FORM PC4050 (10-69) USCOMM-DC 'eos'ie-pes v w uosoGOVERNMENT PRINTING OFFICE: 1969 o--3s6-3 A S(\

1. A gastric cooling apparatus comprising: a. a flexible, inflatable bagfor insertion into a patient''s stomach; b. a water cooling means havingan inlet and an outlet; c. a vacuum operated reservoir means operablyconnected to a vacuum source; d. a directional flow control shunt valve;e. means operatively interconnecting said shunt valve, said reservoirmeans, said water cooling means and said flexible, inflatable bag,whereby when vacuum is applied to the reservoir means, said vacuum willoperate said reservoir means to withdraw a first predetermined amount ofwater from said bag through said valve, and then block off said vacuumto permit said first predetermined amount of water to flow by gravityfrom said reservoir means and through said valve to said water coolingmeans while simultaneously a second predetermined amount of cooled wateris forced out of said cooling means and into said bag.
 2. A gastriccooling apparatus as defined in claim 1, wherein: a. said vacuumoperated reservoir means includes a cylindrical reservoir body having avacuum passage connected at one end thereof which is connected to saidvacuum source, and the other end thereof being connected to said shuntvalve, and a float valve operatively mounted in said reservoir body forblocking said vacuum passage when a predetermined amount of water hasbeen drawn into said reservoir body.
 3. A gastric cooling apparatus asdefined in claim 2, wherein: a. said float valve includes a hollowcylindrical body having a diaphragm on one end thereof for blocking saidvacuum passage and being open at the other end thereof.
 4. A gastriccooling apparatus as defined in claim 3, wherein: a. said float valveincludes a plurality of ports formed through the wall of saidcylindrical body and a weight means movably mounted inside of saidcylindrical body.
 5. A gastric cooling apparatus as defined in claim 4,wherein: a. said reservoir means cylindrical body is provided with avent means at said one end thereof.
 6. A gastric cooling apparatus asdefined in claim 5, wherein: a. said reservoir means vacuum passage isprovided with a check valve means.
 7. A gastric cooling apparatus asdefined in claim 1, wherein: a. said flow control shunt valve includesmeans for providing a first circuit therethrough to interconnect saidbag with said reservoir means when said reservoir means is vacuumoperated, and a second circuit therethrough to interconnect said bagwith said water cooling means and said reservoir means when said firstpredetermined amount of water flows by gravity from said reservoir meansso as to simultaneously force said second predetermined amount of cooledwater into said bag.
 8. A gastric cooling apparatus as defined in claim1, wherein said flow control shunt valve includes: a. a body; b. a firstpassage means formed in said body and having one end interconnected tosaid bag and the other end connected to the outlet end of said watercooling means; c. a second passage means formed in said body and havingone end connected to said reservoir means and the other end connected tosaid first passage means at a point intermediate its ends; d. saidconnecting means including conduit means connecting the inlet end ofsaid water cooling means to said second passage means at a pointintermediate its ends; and, e. a check valve means operatively mountedin each of said first and second passage means at said other ends forcontrolling the flow of water through the water cooling means when thereservoir means discharges water by gravity and for blocking water flowthrough the water cooling means when the reservoir means draws waterfrom the bag.
 9. A gastric cooling apparatus as defined in claim 8,wherein: a. each of said check valve means comprises a ball check valve.10. A gastric cooling apparatus as defined in claim 8, including: a. atemperature indicating means operatively mounted in said first passagemeans in said body for indicating the temperature of the water flowingtherethrough.